AMSIDINE 50mg/ml Concentrate and solvent for solution for infusion (2016)
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Περιεχόμενα
Name of the medicinal product
Amsidine 50mg/ml Concentrate and Solvent for Solution for Infusion.
Qualitative and quantitative composition
Each vial contains 75mg amsacrine in 1.5ml (50mg per ml). Each solvent vial contains 13.5ml of Lactic acid and water for injection to give a concentration of 0.0353M L-Lactic acid. Each ml of the combined ...
Pharmaceutical form
Concentrate and solvent for solution for infusion. Concentrate is a clear, bright orange/red coloured solution and solvent for infusion is clear colourless solution. The pH of the combined solution is ...
Therapeutic indications
Amsidine is indicated for the induction and maintenance of remission in acute leukaemia of adults. It is effective in patients refractory to the anthracycline antibiotics used singly or in combination ...
Posology and method of administration
Intravenous infusion Amsidine must be diluted in 500ml 5% Dextrose Injection BP and infused over 60 to 90 minutes. Phlebitis or pain at the injection site may occur at doses greater than 70 mg/m². (NOTE: ...
Contraindications
Hypersensitivity to amsacrine or acridine derivates; Hypersensitivity to one of the other ingredients of the product; Clear bone-marrow-suppression as a result of treatment with cytostatics or radiotherapy; ...
Special warnings and precautions for use
Amsacrine should only be used under strict control of a specialised oncologist, with preference in institutions with experience with this kind of therapies. Bone Marrow Suppression Amsacrine can cause ...
Interaction with other medicinal products and other forms of interaction
Vaccines Concomitant influenza or pneumococcal vaccination and immunosuppressive therapy have been associated with impaired immune response to the vaccine. Other Protein-binding Drugs Amsacrine may be ...
Fertility, pregnancy and lactation
Pregnancy Data on the usage of this compound during pregnancy in patients are not available to judge possible harmfulness. However based on its pharmacologic activity harmfulness of treatment during pregnancy ...
Effects on ability to drive and use machines
No data about this influence are known. In view of reported adverse effects profile patients are advised after administration of amsacrine to be cautious when driving or using machines.
Undesirable effects
The most common adverse reactions are nausea and/or vomiting, anemia, fever and infection. Pain or phlebitis on infusion has been reported. All patients treated with a therapeutic dosage of amsacrine show ...
Overdose
No specific antidote is known in case of overdosage. Treatment should be symptomatic and supportive. Hemorrhage and infection, resulting from bone marrow hypoplasia or aplasia, may require intensive supportive ...
Pharmacodynamic properties
Amsidine is a sterile antitumour chemotherapeutic agent for intravenous infusion. Although not completely clarified, the mode of action of amsacrine is related to its property of binding the DNA through ...
Pharmacokinetic properties
Amsidine is administered by intravenous infusion. Amsidine has a low lipid solubility, and a relatively high molecular weight, so that it is unlikely that it would cross the blood-brain barrier. Amsidine ...
Preclinical safety data
No additional data of relevance.
List of excipients
Concentrate: N,N Dimethylacetamide Solvent: L-lactic acid Water for injection
Incompatibilities
Amsidine is incompatible with saline. Amsidine in solution reacts with plastic syringes. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Unopened: Amsacrine concentrate vial: 12 months. Unopened: Solvent vial: 12 months. Once opened and diluted with Amsidine solvent: Chemical and physical in-use stability of the reconstituted and diluted ...
Special precautions for storage
Do not store above 25°C. Store in the original pack in order to protect from light and moisture
Nature and contents of container
<u>Concentrate vial:</u> 2ml clear Type I, Ph. Eur. neutral glass vial containing 1.5ml amsacrine solution. <u>Solvent vial:</u> 20ml clear Type I, Ph. Eur. neutral glass vial contains 13.5ml of 0.0353M ...
Special precautions for disposal and other handling
Amsidine should be handled in accordance with local hospital guidelines for handling cytotoxic drugs. Any unused product or waste material should be disposed of in accordance with local requirements. ...
Marketing authorization holder
NordMedica A/S, Jaegersborg, Alle 164, DK-2820, Gentofte, Denmark
Marketing authorization number(s)
PA1828/001/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 05 March 1984 Date of last renewal: 05 March 2009
Date of revision of the text
October 2016
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